510(k) · Cleared
ClearedVarelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia Deutschland GmbH · MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Cleared on May 11, 2004 after an 81-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- May 11, 2004
- Review
- 81 days
- Class
- Class II
- Product code
- MSV
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK040449 Varelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796Pharmacia Deutschland GmbH · 2004
- Descendant · cites it directly · 1 of its ownK091845 Cardiolipin Autoantibody Immunological Test SystemPhadia US, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK151799 EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid…Phadia AB · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040449 | Varelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796 | Pharmacia Deutschland GmbH | 2004 | — |
| +1 | K091845 | Cardiolipin Autoantibody Immunological Test System | Phadia US, Inc. | 2010 | — |
| +2 | K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive… | Phadia AB | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSV device
- #1 K243979 Aptiva APS IgA Reagentscore 10.8 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | INOVA QUANTA Lite B2 GPI IgG Assay Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091845 | Cardiolipin Autoantibody Immunological Test System | 2010 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091845 (Phadia US, Inc., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MSV devicesMSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSV
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · MSV
Too few MSV 510(k)s in any year since 2007 to give a median.
Recalls per year · MSV
No recall names MSV since 2007.
Adverse event reports per year · MSV
No MAUDE report names MSV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Varelisa β2-Glycoprotein I IgG Antibodies EIA kit is designed for the semiquantitative and qualitative determination of β2-glycoprotein I IgG antibodies in serum or plasma.
The presence of β2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040449 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040449: Varelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040449
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026